Overweight or Obesity
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
Interventions
DRUG5 mg BGM0504 injection
5mg BGM0504 injection administered subcutaneously (SC) once a week.
DRUG10 mg BGM0504 injection administered subcutaneously (SC) once a week
10mg BGM0504 injection administered subcutaneously (SC) once a week.
DRUG15 mg BGM0504 injection
15mg BGM0504 injection administered subcutaneously (SC) once a week.
DRUGBGM0504 placebo
BGM0504 placebo administered SC once a week.
Sponsors
BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A male or female aged 18 to 65 years inclusive at screening * BMI≥28 kg/m², or 24.0≤BMI\<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome * Weight change \< 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening * Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study
Exclusion criteria
* Diabetes mellitus * Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening * Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening * Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.; * History of pancreatitis * Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening * Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline,Week 36 | Change from baseline in body weight after 36 weeks of treatment |
| Percentage of Participants Who Achieve≥5% Body Weight Reduction | Baseline,Week 36 | Percentage of Participants Who Achieve≥5% Body Weight Reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve≥5% Body Weight Reduction | Baseline, Week 36 and 52 | Percentage of Participants Who Achieve≥5% Body Weight Reduction |
| Percentage of Participants Who Achieve≥10% Body Weight Reduction | Baseline, Week 36 and 52 | Percentage of Participants Who Achieve≥10% Body Weight Reduction |
| Percentage of Participants Who Achieve≥15%Body Weight Reduction | Baseline, Week 36 and 52 | Percentage of Participants Who Achieve≥15%Body Weight Reduction |
| Percentage of Participants Who Achieve≥20% Body Weight Reduction | Baseline, Week 36 and 52 | Percentage of Participants Who Achieve≥20% Body Weight Reduction. |
| Percent Change From Baseline in Body Weight | Baseline, Week 52 | Percent Change from Baseline in Body Weight after 52weeks of treatment |
| Change From Baseline in Body Mass Index (BMI) | Baseline, Week 36 and 52 | Change From Baseline in Body Mass Index (BMI) after 52weeks of treatment |
| Change From Baseline in Fasting Glucose | Baseline, Week 36 and 52 | Change From Baseline in Fasting Glucose after 52weeks of treatment |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 36 and 52 | Change From Baseline in Hemoglobin A1c (HbA1c) after 52weeks of treatment. |
| Change From Baseline in Waist Circumference | Baseline, Week 36 and 52 | Change From Baseline in Waist Circumference after 52weeks of treatment. |
| Change From Baseline in Body Weight | Baseline, Week36 and 52 | Change from baseline in body weight |
Countries
China
Contacts
Primary ContactJi,MD, chief physician, Peking University People's Hospital
Outcome results
None listed